Kornimate/medical-research-clean huggingface dataset:
preoperative imrt with concurrent apatinib for localised extremity or trunk sarcoma

Conditions: Sarcoma,Soft Tissue; Extremity; Trunk; Intensity-modulated Radiotherapy; Targetd Therapy; Major Wound Complications

Summary: to investigate the safety and efficacy of preoperative imrt and concurrent apatinib for primary truncal or extremity soft tissue sarcoma; to investigate the quality of life and extremity function post-combination treatment; to study the mechanism of radio-sensitizing effects of apatinib for primary truncal or extremity soft tissue sarcoma; to assess the relationship between the mri imaging, pathological findings and local control.


Eligibility criteria:
inclusion criteria: * age older than 18-yo. * histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion. * ecog 0-3 * histology reviewed by reference pathologist * lesion can be assessed * can tolerate radiotherapy and apatinib * agree contraception. * informed consent: all patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed exclusion criteria: * no gross tumor post-resection in other center. * contraindications to apatinib, including allergic to apatinib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, grade 3 to 4 cardiac insufficiency (per nyha criteria), and severe hepatic or renal insufficiency (grade 4), etc. * dermatofibrosarcoma protuberans(dfsp), desmoids, etc. * benign histology * secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) * sts can be cured by extensive operation alone. * previous irradiation to the same area * radiological evidence of distant metastases * other contraindications, can't tolerate operation or other treatment needed in this study. * neoadjuvant chemotherapy given or planned.
nutritional adaptations to physical or sedentary activities in youth

Conditions: Passive Video Games (PVG); Active Video Games (AVG); Exercise (EX)

Summary: sedentary behaviors have been shown to increase food consumption among youth and adults. the recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. to date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. the aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.

after a medical inclusion, the adolescents will have to realise a dxa to assess their body composition and a submaximal exercise to evaluate their aerobic capacities. they will have then to enter the laboratory on three different occasions in a randomized order from 8am to 730pm: at 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) one hour of passive video game; 2) one hour of active video game; 3) a cycling exercise. at 1215 and 0630pm, they will be offered ad libitum meals. at regular intervals through the day, their appetite feelings will be assessed using visual analogue scales. energy expenditure will be assessed thanks to cardiofrequencemeters during the 1h pvg and and by indirect calomitery (k4b2) during the active video game. ad libitum energy consumption will be assessed by investigators and recorded for each participants.

Eligibility criteria:
inclusion criteria: * male * 12-15 years old * bmi defining obesity (cole et al., 2000) * not being under diet restriction * information and consent forms have to be signed by the adolescent and his legal representative * being registered to the national social security system exclusion criteria: * being under medication * contraindication to exercise * smokers * dieting
a study to evaluate the comparative efficacy of cnto 1959 (guselkumab) and secukinumab for the treatment of moderate to severe plaque-type psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

the study consists of screening phase(4 weeks before administration of study drug),active treatment phase(week 0-week 44),follow up phase(week 44-week 56).during various study periods,safety assessments(example\[e.g\] recording of adverse events,vital signs,tuberculosis evaluation,chest radiograph,urine pregnancy test);efficacy assessments(e.g iga,pasi);clinical laboratory assessments(e.g haematology,chemistry);biomarkers/genetic evaluations,will be performed per the study procedures.the primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving pasi 90 response at week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving pasi 90 response at week 48.

Eligibility criteria:
inclusion criteria: * have a diagnosis of plaque-type psoriasis (with or without \[psoriatic arthritis\]psa) for at least 6 months before the first administration of study drug * a woman of childbearing potential must have a negative urine pregnancy test at screening and at week 0 and agree to urine pregnancy testing before receiving injections * agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug * agree not to receive a bacille calmette-guérin (bcg) vaccination during the study, or within 12 months after the last administration of study drug * agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study exclusion criteria: * has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * has previously received guselkumab or secukinumab * has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers * has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly * is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
non-interventional study of ectoin nasal douche (end01) in patients with acute viral rhinosinusitis

Conditions: Acute Rhinosinusitis

Summary: the goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed ectoin nasal douche end01. within the study, end01 will be used as concomitant therapy in addition to the use of a xylometazoline-containing decongestant nasal spray. it will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the ectoin nasal douche as concomitant therapy.

the current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant xylometazoline-containing nasal spray in comparison to use of a decongestant xylometazoline-containing nasal spray together with an ectoin-containing nasal douche in patients with acute viral rhinosinusitis. efficacy will be studied by documentation of the following symptoms: * oedema, redness (assessed by rhinoscopy) * nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste * sore throat, cough in parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries. patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. the assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study. study therapy will be applied in accordance with the respective instructions for use. study duration is 7-14 days, depending on the improvement of symptoms. at the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.

Eligibility criteria:
inclusion criteria: * patients with acute viral rhinosinusitis * presence of common cold symptoms exclusion criteria: * contraindications in accordance with instructions for use * acute bacterial rhinosinusitis * chronic rhinosinusitis

Keywords: rhinosinusitis nasal irrigation nasal douche ectoin
efficacy of wound care and reduction of wound complications by use of aquacel® ag surgical dressing in mis tka

Conditions: Postoperative Complication

Summary: the investigators hypothesized that aquacel® ag surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional sofra-tulle® dressings after minimally invasive total knee arthroplasty (mis-tka).

traditional adhesive dressing (mepore®; mölnlycke health care) for low limb arthroplasty wounds had blistering up to 26%. the jubilee dressing, which consisted of a highly absorbent hydrofiber inner layer and (aquacel; convatec inc.) and a viscoelastic hydrocolloid outer layer (duoderm extra thin; convatec inc.), was introduced for lower limb arthroplasty wounds with lower blistering rate (2% vs. 18%) and lower surgical site infection (1% vs. 3%) compared to traditional adhesive dressing. a new modern dressing regime (aquacel ag surgical dressing; convatec inc.) also reported longer wear time, less dressing change and less blistering. in our institution, the standard wound care after tka was an antimicrobial dressing (sofra-tulle®; royal chem. \& pharm. co., kaohsiung, taiwan) in the inner layer and gauzes in the outer layer. the investigators hypothesized that aquacel® ag surgical dressing would have a significant improvement in the efficacy of wound care and wound complications compared with traditional sofra-tulle® dressings after mis-tka.

Eligibility criteria:
inclusion criteria: * two hundred and eighty five patients who were scheduled for primary unilateral mis-tka were enrolled in the study period. exclusion criteria: * patients with condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, chronic skin disease around the knee (e.g. psoriasis and chronic eczema) and having prior knee replacement, osteotomy or fracture of the ipsilateral knee.

Keywords: dressing tka
comparison between two treatments for burning mouth

Conditions: Burning Mouth Syndrome

Summary: introduction: the management of patients with chronic burning mouth is a challenge in clinical dentistry. objective: to compare the effect of low level laser therapy (lllt) and transcutaneous electrical nerve stimulation (tens) in the treatment of burning mouth. materials and methods: randomized clinical trial consisting of 25 patients with burning mouth who were treated by tens (n=12) and by lllt (n=13). treatment was carried out weekly for 8 weeks. two-way anova was used to verify whether there was a significant difference between times t0 (baseline), t1 (after the 4th treatment session), t2 (after the 8th treatment session) and t3 (30 days after the end of treatment) in in relation to symptoms, analyzed using the visual analog scale, unstimulated salivary flow, xerostomia and dysgeusia with tens and lllt interventions.

experimental group: 20 participants with burning mouth were submitted to transcutaneous electrical nerve stimulation using a device at a frequency of 50 hertz with intensity modulated according to the patient's comfort ranging from 1 - 4 (pulse amplitude) with a duration of 25 minutes per session, with one session per week, totaling eight weeks of treatment at the end of the study. the device's self-adhesive electrodes were fixed on the participant's face, following the path of the trigeminal nerve branch on the side affected by pain and/or burning. control group: 20 participants with burning mouth underwent low power laser therapy with punctual applications of infrared laser (l2) (power of 100mw, 808 nm, 6 joules of energy/60 seconds) in the affected region, keeping one centimeter of distance between the points, until the entire area of the complaint was irradiated. being held one session per week, totaling eight weeks of treatment at the end of the study.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or over * patients with burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions (ihs, 2018) were included in the study, as well as those who presented hyposalivation or some systemic alteration that could be related to a burning sensation in the oral mucosa exclusion criteria: • patients who did not comply with the study treatment protocol.

Keywords: low-level light therapy transcutaneous electric nerve stimulation
safety and efficacy of electronic stimulation for circumferential reduction and muscle toning

Conditions: Fat Necrosis; Muscle Stimulation

Summary: open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. the study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. each subject will receive up to 12 bi-weekly treatments over a 6-week period. follow up visits planned for 2, 30- and 90-days post treatment. measurement outcomes will be compared to baseline.


Eligibility criteria:
inclusion criteria: 1. able to read, understand and voluntarily provide written informed consent. 2. healthy male or female, ≥ 18 years to 65 years of age seeking treatment for improved muscle strength and muscle toning in their core and extremities. 3. subject is determined to be physically fit and agrees to not making any major changes in their diet or lifestyle during the study. 4. able and willing to comply with the treatment/follow-up schedule and requirements. 5. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study as well as have a negative urine pregnancy test at baseline. exclusion criteria: 1. pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months. 2. any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months. 3. history of immunosuppression/immune deficiency disorders (including aids and hiv infection) or use of immunosuppressive medications, 6 months prior to and during the study. 4. history of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding. 5. having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or premalignant pigmented lesions. 6. having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone in the treatment area. 7. suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections. 8. poor skin quality (severe laxity). 9. abdominal wall, muscular abnormality or hernia on physical examination. 10. as per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate. 11. subjects unwilling or unable to adhere to all study requirements for treatment and follow-up. 12. investigator may exclude any subject at any time at his/her discretion.
early evaluation of the mamaact trial

Conditions: Pregnancy Complications

Summary: the mamaact#1 project's aim was to reduce ethnic disparity in stillbirth and infant death by improving the management of pregnancy complications through timely and appropriate response to warning signs of pregnancy. the intervention consisted of a training program for midwives and health education materials for pregnant women. the aim of the feasibility trial was to analyze the acceptability and feasibility of the mamaact intervention using mini-group interviews with midwives and to pilot outcome evaluation using surveys.

the mamaact project's aim was to reduce ethnic disparity in stillbirth and infant death by improving the management of pregnancy complications through timely and appropriate response to warning signs of pregnancy. the intervention was co-created with midwives at hvidovre hospital, the largest maternity ward in denmark. the intervention consisted of a 5-hour training session for midwives in intercultural communication followed by three dialogue meetings in smaller groups. the first midwife visit was extended with 5 minutes allowing for more communication and health education on body symptoms. the women were given a leaflet and a mobile application at this first visit that were describing when and how to respond to warning signs during pregnancy. both the leaflet and application were available in danish, arabic, persian, english, somali, turkish, and urdu. the intervention was a complex intervention, and this phase was a feasibility study preceding a national trial. this feasibility trial was tested at one hospital 2014-2015. the national trial 2017-2021 is registered with clinicaltrials.gov identifier: nct03751774. the hospital had four antenatal clinics and the intervention was implemented at two clinics, while two served as control clinics. the mamaact leaflet and app were distributed to all pregnant women at the two intervention clinics, equivalent n=2000, attending antenatal care during the test period. the aim of the feasibility trial was to analyze the acceptability and feasibility of the trial and to pilot outcome evaluation using surveys in a difference in difference design. the acceptability and feasibility of the intervention were evaluated using mini-groups interviews with midwives in the intervention arm. the difference in difference study was piloted comparing change in outcomes of women from the intervention arm from before the intervention to after the intervention relative to the change in the control arm. survey assessed outcomes were women's' knowledge about warning signs of pregnancy complications, health system navigation and satisfaction with the midwifery based antenatal care.

Eligibility criteria:
inclusion criteria: * pregnant in gestational week 27+0-31+6 , affiliated to hvidovre hospital, seen for antenatal care during recruitment weeks. exclusion criteria: * not speaking danish, english, urdu, turkish, somali, persian or arabic.
2940nm er:yag laser versus benzoyl peroxide gel for the treatment of inflammatory acne

Conditions: Acne Vulgaris

Summary: acne is one of the most common conditions that patients seek for help in dermatological clinic. nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. therefore, interventions to reduce acne are vigorously experimented . lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm erbium:yag laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.


Eligibility criteria:
inclusion criteria: * age 18 year-old to 45 year-old * mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face * fitzpatrick skin phototype i-iv exclusion criteria: * history or clinical presentation of hypertrophic scar or keloid * photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria * oral isotretinoin taken within the last 6 months prior to enrollment * topical retinoid within 4 weeks prior to enrollment * systemic acne therapies (oral antibiotics) within 4 week prior to enrollment

Keywords: acne vulgaris
mindfulness based compassionate living in recurrent depression

Conditions: Recurrent Depression

Summary: since a few years, mindfulness based cognitive therapy (mbct) has been used as treatment for patients suffering from recurrent depression. though a number of studies show that mbct is effective in this population and mbct reduces the chances of relapse/recurrence in recurrent depressive patients, the chance of a new depression developing after end of treatment is still considerable. ergo, there is room for improvement. especially the development of a non-judging or compassionate attitude towards all experience seems to mediate the treatment effect. it is therefore our expectation that a follow-up intervention that focuses specifically on self-compassion could prove very useful in elaborating on the effects of mbct. the research question of this research is therefore: what is the effect of compassion training in people suffering from recurrent depression who have already received mbct training?


Eligibility criteria:
inclusion criteria: 1. recurrent depression according to the dsm-iv criteria. 2. having participated in an mbct training (\>= 4 sessions) exclusion criteria: 1. one or more previous (hypo)manic episodes according to dsm-iv criteria. 2. primary psychotic disorder, e.g. schizophrenia or delusions. 3. clinically relevant neurological conditions (e.g. brain trauma or dementia) or somatic conditions (e.g. cancer, aids) that could be related to the depression. 4. current alcohol and/or drug abuse. 5. use of high dosages of benzodiazepines. 6. recent electro convulsive therapy (ect) (less than 3 months ago). 7. problems impeding participating in a group, such as severe borderline personality disorder. 8. no prior experience with mbct. 9. problems impeding completing the questionnaires, such as cognitive dysfunctions (only assessed if suspected). 10. subnormal intelligence (iq \< 80) (only assessed if suspected).

Keywords: randomised controlled trial recurrent depression mindfulness training compassion training (mbcl) fear of compassion added value compassion